Biostatistics

People

Charles F. Contant, PhD, MPH – Director

Satishkumar Mohanavelu, MS – Statistician
Jie Qin, MS – Statistician
Sarah Sloan, MS, MA – Statistician

Design of Studies

Phase III Clinical Trials – Design of clinical trials using time-to-event, binary and/or continuous outcomes are offered by the biostatistics group at TIMI. We have the capability to model accrual rates, time-varying hazards and hazard ratios, loss-to-follow-up patterns, stratification and cross-over from one treatment to the other. Sample sizes and power are computed using Section 508 compliant software.

Phase II Clinical Trial – Design of both late Phase II studies as well as Proof of Concept Studies. Late Phase II studies examining multiple doses with efficient multiple-comparisons adjusted assessments of each dose to placebo (or comparator) are available. Proof of Concept Studies can be designed using standard techniques or Bayesian Dose Response Modeling techniques.

Analyses of Studies

We provide analyses of datasets to verify sponsor analyses. Both simple and complex models are available and explanation of results both verbally and with appropriate graphics is provided. Analyses in support of primary, secondary and subgroups in support of publications are offered. Both frequentist and Bayesian methods can be use.

Risk Score Development and Prognostic Models

Using modern regression and model building techniques, we build and evaluate risk score and prognostic models for clinical outcomes. We base these models on the large data sets available at TIMI